Instructions For Use; How Supplied - INVATEC Pacific Xtreme Instrucciones De Uso

Dilatation-related:
− Dissection of the dilated artery
− Hypotension
− Arrhythmia
− Death
− Perforation of the artery wall
− Prolonged spasms
− Acute re-occlusion necessitating a surgical intervention
NOTE: Dilation of carotid- and supra-aortic arteries may cause (as well
during predilation and/or post-dilation, transitional neurological deficits
(such as TIA, PRIND) or permanent, with possible lethal consequences.

INSTRUCTIONS FOR USE

Prior to angioplasty, carefully examine all equipment to be used during
the procedure, including the dilatation catheter, to verify proper function.
Verify that the catheter and sterile packaging have not been damaged in
shipment and that the catheter size is suitable for the specific procedure
for which it is intended.
Inflation Device Preparation
Carefully remove the balloon protective sheath. Prior to use, carefully
examine the unit to verify that the catheter or sterile package has not
been damaged in shipment. After moistening the balloon protection
sheath with physiological saline solution, carefully remove the balloon
protection sheath not to damage the balloon part. In case of resistance,
twist the protection with one hand holding the shaft with the other.
TO DISPLACE AIR: Flush out the lumen for the guide wire by
connecting a syringe filled with saline solution. Start flushing until liquid
rinses out of guidewire lumen at the distal tip of the balloon catheter.
Avoid manipulation of the balloon catheter during removal from
packaging and flushing of guide wire lumen.
Insertion Technique
− Access to the vessel must be sufficiently patent, or sufficiently
recanalized, to proceed with further intervention.
− In case the guide wire has not already been positioned across
the lesion, under fluoroscopy, insert a 0.018" (0.46mm) guide wire
across the lesion, following standard PTA techniques.
− Insert the proximal end of the guide wire into the distal tip of the
catheter.
− Carefully insert the PTA balloon catheter through the introducer
sheath and, under fluoroscopic guidance, carefully advance it
through the peripheral vasculature following the guide wire towards
the lesion.
CAUTION: Do not advance the guide wire or the balloon catheter if
resistance is met without first determining the cause of resistance and
taking remedial action.
− Position the balloon within the lesion using the two radiopaque
markers located on the shaft as reference points for precise
placement across the target lesion.
NOTE: To avoid kinking, advance the dilatation catheter slowly, in small
increments until the proximal end of the guide wire emerges from the
hub.
Balloon Inflation
CAUTION: Use only a mixture of contrast medium and saline solution
to fill the balloon (1:1). A contrast mix of 70% saline and 30% contrast
media is recommended with balloon lengths ≥ 200mm. Never use air or
any gaseous medium to inflate the balloon of the catheter.
− Connect a syringe containing contrast medium to the Luer
connector located at the proximal hub of the balloon catheter and
apply negative pressure for about 15 seconds until no bubbles
appear in the contrast medium solution. Return to atmospheric
pressure allowing contrast medium flow into the catheter lumen.
Remove the syringe leaving a meniscus of contrast in the hub of
the balloon lumen.
− Remove air bubbles from the inflation device following the
manufacturer's instructions.
− Using stopcock attach inflation device to the PTA balloon catheter.
Avoid air entering the system.
IFU_pcf_0110107-01.indd 6
− Open stopcock on inflation device. Inflate the dilation balloon
gradually to dilate the lesion to the calculated diameter in
accordance with the Compliance Chart. Apply a constant pressure
for about 60 seconds.
CAUTION: Do not exceed Rated Burst Pressure (RBP)
Balloon deflation and removal
Deflate the balloon in accordance with standard PTA procedures. Apply
negative pressures to the balloon for about 30 - 120 sec until the balloon
is empty. Ensure the balloon is fully deflated before pulling carefully the
catheter out of the vessel.

HOW SUPPLIED

The PACIFIC™ XTREME PTA balloon catheter is supplied sterile and
intended for single use only. The PACIFIC™ XTREME is sterilized by
ethylene oxide gas. It will remain sterile as long as the packaging remains
unopened and undamaged. Use product prior to labeled "Use By" date.
CAUTION: Do not use if the inner package is open or damaged.
RE-WRAPPING TOOL – TO REGAIN PROPER BALLOON DESIGN
AFTER mULTIPLE USAGE IN THE SAmE PATIENT
A balloon re-wrap tool attached to the compliance chart may be
available depending on device size. The re-wrap tool is a red sleeve
with a calibrated inner diameter and is designed to assist in folding the
balloon portion of the catheter after the first or subsequent inflation.
Re-wrapping the balloon aids introduction and withdrawal of the balloon
catheter.
NOTE: All balloons are shipped pre-wrapped. The balloon wrap may
relax over time. The following technique may be used to enhance the
wrap when necessary:
1. Apply suction to the balloon lumen and maintain during the re-
wrapping process. As the balloon deflates pleats will be visible.
2. Facing the distal tip of the catheter manually wrap the pleats
around the catheter body in a counterclockwise direction.
3. While pressing the pleats against the catheter, slide the balloon
rewrap tool over the balloon (for certain balloon lengths only).
STORAGE
Store at controlled room temperature, in a dry place. Keep away from
sunlight. Do not expose to organic solvents (e.g. alcohol), ionizing
radiation or ultraviolet light. Rotate inventory so that catheters are used
prior to the expiration date on package label.
WARRANTy / LIABILITy
The product and each component of its system have been designed,
manufactured, tested and packaged with all reasonable care. The
warnings contained in Invatec's instructions for use are expressly to
be considered as an integral part of this provision. Invatec guarantees
the product until the expiry date indicated on the same. The warranty
is valid provided that the use of the product was consistent with the
instructions for use. Invatec disclaims any warranty of merchantability
or fitness for a particular purpose of the product. Invatec is not
liable for any direct, indirect, incidental or consequential damages
caused by the product. Except in the case of fraud or grave fault on
Invatec's part, compensation of any damage to the buyer will not, in
any event, be greater than the invoice price of the disputed products.
The guarantee contained in this provision incorporates and substitutes
the legal guarantees for defects and compliance, and excludes any
other possible liability of Invatec, however originating, from the product
supplied. These limitations of liability and warranty are not intended
to contravene any mandatory provisions of law applicable. If any
clause of the disclaimer is considered by a competent court to be
invalid or to be in conflict with the applicable law, the remaining part
of it shall not be affected and remain in full force and effect. The
invalid clause shall be substituted by a valid clause which best reflects
Invatec's legitimate interest in limiting its liability or warranty. No person
has any authority to bind Invatec to any warranty or liability regarding
the product.
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